DeviceClearance

EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE— 510(k) K031946

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K031946 for EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE, Substantially Equivalent on 2003-11-03. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant
Edwards Lifesciences, LLC
Product code
Code DTM
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Milpitas, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.